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Assessing the Impact of MOVALIS in Osteoarthritis and Rheumatoid Arthritis Patients on Health Related Quality of Life

NCT ID: NCT00619177

Last Updated: 2015-02-16

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3569 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-03-31

Brief Summary

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The objective of the observational study is to examine the effect of MOVALIS (Meloxicam) therapy on Health Related Quality of Life (HRQoL) in the diverse region of Central and Eastern Europe. The Medical Outcomes Study 12 Item Short Form Health Survey version 2 (SF-12v2) will be used as the instrument to measure any change in physical wellbeing (Physical Component Summary, PCS) and mental wellbeing (Mental Component Summary, MCS) of patients following MOVALIS (Meloxicam) therapy.

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Detailed Description

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Conditions

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Osteoarthritis Arthritis, Rheumatoid

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

1\. Male or female patients aged 18 years or above 2 Females of child bearing age must be using adequate contraception (hormonal or barrier method of birth control) 3. Patients with symptoms of acute, painful osteoarthritis or rheumatoid arthritis 4. Patients requiring therapy with non-steroidal anti-inflammatory drugs (NSAIDs) 5. Patients requiring either parenteral and/or oral NSAIDs 6. Patients who have not taken another NSAID or Cyclo-oxygenase-2 (COX-2) inhibitor in the previous 7 days Pain intensity on the visual analogue scale (VAS) 25 mm and above

Exclusion Criteria

1. Known hypersensitivity to meloxicam or any excipient of the product, known or suspected hypersensitivity to analgesics, antipyretics or NSAIDs
2. Patients who have developed signs of asthma, nasal polyps, angio-oedema or urticaria following the administration of aspirin or other NSAIDs
3. Active peptic ulcer, gastrointestinal perforation or bleeding within the last 6 months
4. Severe liver failure
5. Non-dialysed severe renal failure
6. Pregnancy or breastfeeding
7. Haemostasis disorders or concomitant treatment with anticoagulants
8. Severe congestive heart failure
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Boehringer Ingelheim

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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Boehringer Ingelheim Investigational Site

Split, , Croatia

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Boehringer Ingelheim Investigational Site

Zagreb, , Croatia

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Boehringer Ingelheim Investigational Site

Aš, , Czechia

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Boehringer Ingelheim Investigational Site

Babice, , Czechia

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Boehringer Ingelheim Investigational Site

Benátky nad Jizerou, , Czechia

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Benesov Nad Ploucnicí, , Czechia

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Boehringer Ingelheim Investigational Site

Benesov U Prahy, , Czechia

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Boehringer Ingelheim Investigational Site

Benešov, , Czechia

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Beroun, , Czechia

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Bílina, , Czechia

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Bílovec, , Czechia

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Bílovice nad Svitavou, , Czechia

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Blansko, , Czechia

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Blatnice pod Svatým Antonínkem, , Czechia

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Bohusovice Nad Ohrí, , Czechia

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Bolatice, , Czechia

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Boskovice, , Czechia

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Bratríkov, , Czechia

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Brno, , Czechia

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Broumov, , Czechia

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Bruntál, , Czechia

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Břeclav, , Czechia

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Buchlovice, , Czechia

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Bystřice nad Pernštejnem, , Czechia

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Byšice, , Czechia

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Cáslav, , Czechia

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Ceská Lípa, , Czechia

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Ceská Trebová, , Czechia

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Ceské Budojovice, , Czechia

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Ceský Tesín, , Czechia

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Cheb, , Czechia

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Chodov, , Czechia

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Chomutov, , Czechia

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Chropyně, , Czechia

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Chrudim, , Czechia

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Černošice, , Czechia

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Černožice, , Czechia

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Decín, , Czechia

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Dobrís, , Czechia

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Dobruška, , Czechia

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Dobřany, , Czechia

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Dol . Lou., , Czechia

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Dolní Benesov, , Czechia

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Dolní Berkovice, , Czechia

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Domažlice, , Czechia

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Drnovice, , Czechia

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Dvur Králové Nad Labem, , Czechia

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Frenstát, , Czechia

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Fryštát, , Czechia

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Frýdek-Místek, , Czechia

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Frýdlant, , Czechia

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Fulnek, , Czechia

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Hanušovice, , Czechia

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Havírov, , Czechia

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Havlíckuv Brod, , Czechia

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Heřmanův Městec, , Czechia

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Hlucín, , Czechia

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Hluk, , Czechia

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Hodonice, , Czechia

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Holice, , Czechia

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Horice V Podkrkonosí, , Czechia

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Horní Berkovice, , Czechia

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Horní Slavkov, , Czechia

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Hořovice, , Czechia

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Hostinné, , Czechia

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Hošťka, , Czechia

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Hradec Králové, , Czechia

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Hrádek n.N., , Czechia

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Hronov, , Czechia

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Hrušovany nad Jevišovkou, , Czechia

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Hulín, , Czechia

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Hustopece U Brna, , Czechia

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Hustopeče, , Czechia

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Jablonec, , Czechia

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Jablonec n.N., , Czechia

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Jablunkov, , Czechia

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Jaroměř, , Czechia

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Javorník, , Czechia

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Jeseník, , Czechia

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Jicín, , Czechia

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Jihlava, , Czechia

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Jirkov, , Czechia

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Kadaň, , Czechia

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Kaplice, , Czechia

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Karlovy Vary, , Czechia

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Kladno, , Czechia

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Klatovy, , Czechia

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Klásterec N. Ohrí, , Czechia

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Klobouky u Brna, , Czechia

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Kolín, , Czechia

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Konice, , Czechia

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Kopřivnice, , Czechia

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Kosmonosy, , Czechia

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Kostelec nad Orlicí, , Czechia

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Kralupy nad Vltavou, , Czechia

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Králuv Dvur, , Czechia

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Krnov, , Czechia

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Kromeríz, , Czechia

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Krouna, , Czechia

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Krupka, , Czechia

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Kunovice, , Czechia

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Kuřim, , Czechia

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Kyjov, , Czechia

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Lanškroun, , Czechia

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Ledec Nad Sázavou, , Czechia

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Lenešice, , Czechia

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Letohrad, , Czechia

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Liberec, , Czechia

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Liběšice, , Czechia

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Libochovice, , Czechia

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Lipová Lázne, , Czechia

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Litoměřice, , Czechia

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Litovel, , Czechia

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Litvínov, , Czechia

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Lomnice n.P., , Czechia

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Louny, , Czechia

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Lovosice, , Czechia

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Ludgérovice, , Czechia

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Mariánské Lázne, , Czechia

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Melník, , Czechia

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Město Albrechtice, , Czechia

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Milín, , Czechia

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Milovice, , Czechia

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Míretice, , Czechia

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Mladá Boleslav, , Czechia

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Mlázovice, , Czechia

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Mnísek Pod Brdy, , Czechia

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Modřice, , Czechia

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Mohelnice, , Czechia

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Mor.Budejovice, , Czechia

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Mor.Krumlov, , Czechia

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Mor.Nová Ves, , Czechia

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Moravany, , Czechia

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Most, , Czechia

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Mýto, , Czechia

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Nasavrky, , Czechia

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Náchod, , Czechia

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Námest Nad Oslavou, , Czechia

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Nechanice, , Czechia

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Neratovice, , Czechia

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Nová Ves Pod Plesí, , Czechia

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Nové Mesto Nad Metují, , Czechia

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Nový Bor, , Czechia

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Nový Bydzov, , Czechia

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Nový Jicín, , Czechia

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Nový Knín, , Czechia

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Nymburk, , Czechia

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Obrataň, , Czechia

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Obríství, , Czechia

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Olomouc, , Czechia

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Opava, , Czechia

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Opočno, , Czechia

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Orlová, , Czechia

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Ostrava, , Czechia

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Otrokovice, , Czechia

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Pacov, , Czechia

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Pardubice, , Czechia

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Pelhřimov, , Czechia

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Petřvald, , Czechia

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Pierov, , Czechia

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Pilsen, , Czechia

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Písek, , Czechia

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Planá, , Czechia

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Polná, , Czechia

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Postoloprty, , Czechia

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Postřelmov, , Czechia

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Prachatice, , Czechia

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Prague, , Czechia

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Príbram, , Czechia

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Prostějov, , Czechia

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Přelouč, , Czechia

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Přeštice, , Czechia

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Radonice, , Czechia

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Rakovník, , Czechia

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Raspenava, , Czechia

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Rícany U Brna, , Czechia

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Rokycany, , Czechia

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Roudnice nad Labem, , Czechia

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Rožnov pod Radhoštěm, , Czechia

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Ruda nad Moravou, , Czechia

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Rudná U Prahy, , Czechia

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Rumburk, , Czechia

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Rychnov nad Kněžnou, , Czechia

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Slušovice, , Czechia

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Smidary, , Czechia

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Smiřice, , Czechia

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Studená, , Czechia

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Studénka, , Czechia

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Tábor, , Czechia

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Třešť, , Czechia

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Ústek, , Czechia

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Ústí nad Labem, , Czechia

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Vamberk, , Czechia

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Varnsdorf, , Czechia

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Vápenná, , Czechia

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Velká Bítes, , Czechia

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Velké Mezirící, , Czechia

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Velké Opatovice, , Czechia

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Velké Porící, , Czechia

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Veselí nad Moravou, , Czechia

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Vintírov, , Czechia

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Vlašim, , Czechia

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Vodňany, , Czechia

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Votice, , Czechia

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Vrbno pod Pradědem, , Czechia

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Vsetín, , Czechia

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Vyškov, , Czechia

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Elva, , Estonia

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Haapsalu, , Estonia

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Jõhvi, , Estonia

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Kohtla-Järve, , Estonia

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Kose, , Estonia

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Laane-Virumaa, , Estonia

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Narva, , Estonia

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Paide, , Estonia

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Boehringer Ingelheim Investigational Site

Parne, , Estonia

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Boehringer Ingelheim Investigational Site

Põlva, , Estonia

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Rakvere, , Estonia

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Sillamäe, , Estonia

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Tallinn, , Estonia

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Tartu, , Estonia

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Viljandi, , Estonia

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Bryansk, , Russia

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Dmitrov, , Russia

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Dolgoprudnii, , Russia

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Boehringer Ingelheim Investigational Site

Dzerzhinsk, , Russia

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Boehringer Ingelheim Investigational Site

Gukovscii, , Russia

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Boehringer Ingelheim Investigational Site

Ivanovo, , Russia

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Boehringer Ingelheim Investigational Site

Moscow, , Russia

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Boehringer Ingelheim Investigational Site

Nizhny Novgorod, , Russia

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Boehringer Ingelheim Investigational Site

Podolsk, , Russia

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Boehringer Ingelheim Investigational Site

Ryazan, , Russia

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Boehringer Ingelheim Investigational Site

Smolensk, , Russia

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Boehringer Ingelheim Investigational Site

Vladimir, , Russia

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Boehringer Ingelheim Investigational Site

Yaroslavl, , Russia

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Boehringer Ingelheim Investigational Site

Bardejov, , Slovakia

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Boehringer Ingelheim Investigational Site

Bánovce/Bebravou, , Slovakia

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Boehringer Ingelheim Investigational Site

Bošany, , Slovakia

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Boehringer Ingelheim Investigational Site

Bran?, , Slovakia

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Boehringer Ingelheim Investigational Site

Handlová, , Slovakia

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Boehringer Ingelheim Investigational Site

Humenné, , Slovakia

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Boehringer Ingelheim Investigational Site

Kežmarok, , Slovakia

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Boehringer Ingelheim Investigational Site

Kluknava, , Slovakia

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Boehringer Ingelheim Investigational Site

Košice, , Slovakia

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Boehringer Ingelheim Investigational Site

Krompachy, , Slovakia

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Boehringer Ingelheim Investigational Site

Liptovský Mikulás, , Slovakia

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Boehringer Ingelheim Investigational Site

Malacky, , Slovakia

Site Status

Boehringer Ingelheim Investigational Site

Martin, , Slovakia

Site Status

Boehringer Ingelheim Investigational Site

Michalovce, , Slovakia

Site Status

Boehringer Ingelheim Investigational Site

Námestovo, , Slovakia

Site Status

Boehringer Ingelheim Investigational Site

Nitra, , Slovakia

Site Status

Boehringer Ingelheim Investigational Site

Nove Mesto/Váhom, , Slovakia

Site Status

Boehringer Ingelheim Investigational Site

Pies?any, , Slovakia

Site Status

Boehringer Ingelheim Investigational Site

Poprad, , Slovakia

Site Status

Boehringer Ingelheim Investigational Site

Prešov, , Slovakia

Site Status

Boehringer Ingelheim Investigational Site

Ružomberok, , Slovakia

Site Status

Boehringer Ingelheim Investigational Site

Saint ?ubov?a, , Slovakia

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Boehringer Ingelheim Investigational Site

Se?ovská Polianka, , Slovakia

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Boehringer Ingelheim Investigational Site

Senec, , Slovakia

Site Status

Boehringer Ingelheim Investigational Site

Spisská Nová Ves, , Slovakia

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Boehringer Ingelheim Investigational Site

Stará Turá, , Slovakia

Site Status

Boehringer Ingelheim Investigational Site

Stropkov, , Slovakia

Site Status

Boehringer Ingelheim Investigational Site

Svinia, , Slovakia

Site Status

Boehringer Ingelheim Investigational Site

Topo??any, , Slovakia

Site Status

Boehringer Ingelheim Investigational Site

Torna?a, , Slovakia

Site Status

Boehringer Ingelheim Investigational Site

Trebišov, , Slovakia

Site Status

Boehringer Ingelheim Investigational Site

Tren?ín, , Slovakia

Site Status

Boehringer Ingelheim Investigational Site

Trhovište, , Slovakia

Site Status

Boehringer Ingelheim Investigational Site

Vranov/Top?ou, , Slovakia

Site Status

Boehringer Ingelheim Investigational Site

Vrútky, , Slovakia

Site Status

Boehringer Ingelheim Investigational Site

Žilina, , Slovakia

Site Status

Countries

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Croatia Czechia Estonia Russia Slovakia

Other Identifiers

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107.273

Identifier Type: -

Identifier Source: org_study_id

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